The aim of the present study was to develop optimal dissolution conditions for a BCS Class II drug in early development. The model drug efavirenz was formulated in two dosage forms: a classical immediate-release suspension and modified-release cubosomes. Dissolution studies were carried out in classical and biorelevant media adapted to early development using animal models to confirm the in vitro findings. The percentage drug dissolved was calculated in all media, and the percentage absorbed was calculated from in vivo data. Level A IVIVC was investigated in all media, and the best one selected based on the highest r 2 value. Optimal dissolution media that could be used as starting points for further development are 0.5% SLS in water for cubosomes and fasted-state simulated intestinal fluid (FaSSIF) for suspensions. The predicted plasma profiles show appropriate contour, and the internal prediction error was at most 12% for the predicted parameters C max and AUC. Thus, a simple approach was used for developing IVIVC based on animal in vivo data, which can be used as a quick and simple alternative tool in early development stage depending on which dissolution method can be optimized even before human studies.
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